Dexmedetomidine to Levobupivacaine for Transversus Abdominis Plane Block in Elderly Patients Undergoing Inguinal Hernia Repair Surgery

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT04971759
Collaborator
(none)
90
1
3
14.1
6.4

Study Details

Study Description

Brief Summary

The perioperative management of pain following abdominal surgery can pose a challenge to anesthesia providers. Conventional practice has involved the use of opioids as well as neuraxial analgesic techniques. Unfortunately, these therapies are not without potential risks and side effects. These include nausea, vomiting, pruritus, urinary retention, constipation, respiratory depression, and sedation.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Detailed Description

As a result, the goal to reduce perioperative pain has taken on a multimodal approach.

Multimodal or "balanced" analgesia uses a combination of opioid and nonopioid analgesics to improve pain control and minimize opioid-related side effects. These include the use of nonsteroidal anti-inflammatory drugs, local anesthetics, peripheral nerve blocks, gabapentinoids, and alpha2 adrenergic agonists. Any combination of these therapies can help reduce the surgical stress response and improve patient outcomes such as pain control, patient satisfaction, time to discharge, and return to daily activities.

One method used in this multimodal approach is the transversus abdominis plane block. As first described by Rafi in 2001, this block provides analgesia to the anterolateral abdominal wall. In 2007, further studied this technique in patients undergoing large-bowel resection. He discovered a reduction in postoperative pain and morphine consumption in the first 24 hours postoperatively, resulting in fewer opioid-mediated side effects. In this same year, Hebbard described the use of ultrasound guidance to provide real-time imaging of the muscle layers and needle placement to improve TAP block accuracy. In 2008, Hebbard. described the subcostal approach of TAP blocks, to target the nerves of the upper abdomen. Transversus abdominis plane blocks continue to be studied and developed as an effective method for providing analgesia for numerous types of abdominal surgeries.

Study Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Addition of Dexmedetomidine to Levobupivacaine for Transversus Abdominis Plane Block in Elderly Patients Undergoing Inguinal Hernia Repair Surgery: Could it Make a Difference?
Actual Study Start Date :
Dec 1, 2019
Actual Primary Completion Date :
Dec 30, 2020
Actual Study Completion Date :
Feb 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group L

30 Patients will receive Levobupivacaine 5%

Drug: Levobupivacaine
Levobupivacaine 5%

Experimental: LD group

30 patients will receive Levobupivacaine 5% + 1 µg/kg dexmedetomidine.

Drug: Dexmedetomidine Hydrochloride
Levobupivacaine 5% + 1 µg/kg dexmedetomidine.

Experimental: LF group

30 patients will receive Levobupivacaine 5% + 1µg/kg fentanyl

Drug: Fentanyl
Levobupivacaine 5% + 1µg/kg fentanyl

Outcome Measures

Primary Outcome Measures

  1. first analgesic request [24 hours postoperative]

    time for the first analgesia rescue call.

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • ASA status I, II, and III patients,

  • aged 60-75 y,

  • both male and female,

  • undergoing inguinal hernia repair surgery.

Exclusion Criteria:
  • morbid obesity (BMI > 40),

  • spine metastatic tumor, allergy to an amide LA, or magnesium sulfate,

  • heart block, renal, or liver dysfunction, substance abuse disorder, chronic opioid use, or electrolyte disturbance, administration of any sedative, preexisting mental illness, psychological or emotional problems.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assiut governorate Assiut Egypt

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ghada Mohammed AboelFadl, Principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT04971759
Other Study ID Numbers:
  • 17300618
First Posted:
Jul 21, 2021
Last Update Posted:
Jul 21, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 21, 2021